#China #Shenzhen #AKG #Xin Tianhe #Ca-AKG

Xin Tianhe Biotechnology Achieves Historic GRAS Certification

On January 7, 2026, Xin Tianhe Biotechnology celebrated a milestone achievement when its AKG (alpha-ketoglutaric acid) and Ca-AKG products successfully passed the Self-GRAS (Generally Recognized As Safe) scientific evaluation under the standards set by the U.S. FDA. This accomplishment is notable as it marks the first domestic fermentation products to receive such authoritative certification in the nation. It opens doors for these products to enter the lucrative U.S. market, highlighting a significant leap towards capturing a stake in the global nutrition and health sector.

Understanding AKG's Significance

Alpha-ketoglutaric acid is commonly recognized as a vital player in the tricarboxylic acid cycle, an essential pathway for energy metabolism in living organisms. As per U.S. regulations, AKG has been designated as an old dietary ingredient, which allows it to be used legally as a food raw material. What sets Xin Tianhe apart, however, is its innovative approach: while traditional synthetic methods are typically employed for flavoring agents, Xin Tianhe utilizes a biological fermentation process that allows their product to serve directly as a "food raw material." This unique methodology emphasizes the benefits associated with its core offerings.

Technological Innovation Behind the Products

Xin Tianhe's innovation does not stop at the fermentation method; the company utilizes its proprietary CynbioX™AKG, which embraces a full-cell catalytic technique. This method employs the internationally recognized food-grade Corynebacterium glutamicum as a carrier, ensuring that the product maintains high safety and quality standards from its inception. The dual-enzyme expression system utilized effectively reduces impurities while enhancing the overall purity of the end product.

As a leader in the innovative application of AKG on a global scale, Xin Tianhe prides itself on leveraging cutting-edge technology and eco-friendly manufacturing as its competitive advantages. Its parent company’s strong research and development capacity has allowed Xin Tianhe to build an advanced synthetic biology technology platform. Additionally, the company has secured various quality assurances, including KOSHER, FSSC 22000, and HALAL certifications, reflecting adherence to international standards.

R&D and Scientific Validation

In its quest for product excellence and efficacy, Xin Tianhe has conducted extensive research on both domestic and international literature. Furthermore, the effectiveness of AKG in areas such as anti-aging, muscle building, and enhancing athletic performance has been substantiated through multi-dimensional experiments, primarily conducted with animal models. Some of these significant findings have been documented in internationally recognized scientific journals, providing a strong scientific foundation for ongoing product innovation and development.

Expanding Global Market Presence

The successful acquisition of the Self-GRAS certification showcases Xin Tianhe’s robust capabilities in product research, development, and quality assurance. This achievement sets a firm groundwork for expanding its reach in the global nutrition and health market. The rising demand for AKG, particularly in sectors related to anti-aging, beauty, sports nutrition, and weight management, presents numerous opportunities for the company.

Looking ahead, Xin Tianhe plans to harness its certification advantages and technological advancements to establish a formidable presence in the global AKG market. The company is poised to lead in innovative developments in the nutrition and health sectors, driven by its unwavering commitment to quality and scientific research.

In conclusion, Xin Tianhe Biotechnology’s recent certification not only marks a critical junction in its journey but also highlights the growing importance of innovative and safe biotechnological solutions in the health and nutrition arena, ensuring a healthier future for consumers worldwide.